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Study Complete
Sponsor ID
2012-005

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple MyelomaCLARION

Sponsor ID
2012-005
Clinicaltrials.gov ID
NCT01818752
EUCTIS ID
N/A
EudraCT ID
2012-005283-97
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Study Details

The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
955
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-Free Survival

Timeframe: 36 months

Secondary Outcome Measures

Overall Survival (OS)

Timeframe: 36 months

Complete Response (CR) rate

Timeframe: 36 months

Overall Response Rate (ORR)

Timeframe: 36 months

Change from baseline in health-related quality of life (HR-QOL) score

Timeframe: 36 months

Locations

Location
Status
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Location
California Cancer Associates for Research & Excellence, Inc. (cCARE)
Fresno, California, United States, 93720
Status
Active, not recruiting
Location
Marin Cancer Care
Greenbrae, California, United States, 94904
Status
Active, not recruiting
Location
Sutter Gould Medical Foundation
Modesto, CA, United States, 95357
Status
Active, not recruiting
Location
Sharp Memorial Hospital
San Diego, California, United States, 92123
Status
Withdrawn
Location
Innovative Clinical Research Institute
Whittier, California, United States, 90603
Status
Active, not recruiting
Location
UF Health Shands Cancer Hospital
Gainesville, FL, United States
Status
Active, not recruiting
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Study Info
Age
18+ years
Condition
  • Multiple Myeloma
    • Sex
    All
    Trial Dates
    Jul 2013 - Jul 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria) 2. Transplant ineligibility 3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization): • Serum M-protein ≥ 0.5 g/dL, or • Urine M-protein ≥ 200 mg/24 hours, or • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio < 0.26 or > 1.65) 4. No prior treatment for multiple myeloma 5. Eastern Cooperative Oncology Group (ECOG) performance status 0–2
    Exclusion Criteria:
    1. Multiple myeloma of IgM (immunoglobulin M) subtype 2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone 3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) 5. Waldenström macroglobulinemia (WM) 6. Known amyloidosis